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Document 32024R0197

Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances

C/2023/6928

OJ L, 2024/197, 5.1.2024, ELI: http://data.europa.eu/eli/reg_del/2024/197/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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ELI: http://data.europa.eu/eli/reg_del/2024/197/oj

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Official Journal
of the European Union

Series L

2024/197

5.1.2024

COMMISSION DELEGATED REGULATION (EU) 2024/197

of 19 October 2023

amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (1), and in particular Article 37(5) thereof,

Whereas:

(1)	Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 contains the list of harmonised classification and labelling of hazardous substances based on the criteria set out in Parts 2 to 5 of Annex I to that Regulation.

(2)

Proposals to introduce harmonised classification and labelling of certain substances and to update the harmonised classification and labelling of certain other substances have been submitted to the European Chemicals Agency (the ‘Agency’) pursuant to Article 37 of Regulation (EC) No 1272/2008. The Committee for Risk Assessment of the Agency (RAC) adopted, after having taken account of the comments received from the parties concerned, the following opinions (2) on those proposals:

—	Opinion of 18 March 2021 concerning benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate;

—	Opinion of 18 March 2021 concerning benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1);

—	Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1);

—	Opinion of 18 March 2021 concerning reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1);

—	Opinion of 18 March 2021 concerning 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF;

—	Opinion of 18 March 2021 concerning cinnamaldehyde; 3-phenylprop-2-enal; cinnamic aldehyde; cinnamal [1], (2E)-3-phenylprop-2-enal [2];

—	Opinion of 18 March 2021 concerning benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine;

—	Opinion 18 March 2021 concerning 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate;

—	Opinion of 18 March 2021 concerning foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea;

—	Opinion of 18 March 2021 concerning ethyl acrylate;

—	Opinion of 18 March 2021 concerning methyl acrylate;

—	methyl propenoate;

—	Opinion of 18 March 2021 concerning methyl methacrylate; methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate;

—	Opinion of 18 March 2021 concerning transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate;

—	Opinion of 18 March 2021 concerning allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester;

—	Opinion of 18 March 2021 concerning mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride;

—	Opinion of 10 June 2021 concerning triethylamine;

—	Opinion of 10 June 2021 concerning di-n-butylamine;

—	Opinion of 10 June 2021 concerning 4-nitrosomorpholine;

—	Opinion of 10 June 2021 concerning difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether;

—	Opinion 10 June 2021 concerning N,N-dimethyl-p-toluidine;

—	Opinion of 10 June 2021 concerning potassium chlorate;

—	Opinion of 10 June 2021 concerning sodium chlorate;

—	Opinion of 10 June 2021 Concerning reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane;

—	Opinion of 10 June 2021 concerning metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one;

—	Opinion 16 September 2021 concerning lithium carbonate [1] lithium chloride [2] lithium hydroxide [3];

—	Opinion of 16 September 2021 concerning dimethyl propylphosphonate;

—	Opinion of 16 September 2021 concerning dibutyltin maleate;

—	Opinion of 16 September 2021 concerning dibutyltin oxide;

—	Opinion of 16 September 2021 concerning clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine;

—	Opinion of 16 September 2021 concerning cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide;

—	Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with average molecular weight < 352 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—	Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 352 g/mol ≤ average molecular weight < 704 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—	Opinion of 16 September 2021 concerning nonylphenol, branched and linear, ethoxylated (with 704 g/mol ≤ average molecular weight ≤ 1 540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof];

—	Opinion of 16 September 2021 concerning 1-phenylethan-1-one (1-phenylethylidene)hydrazone;

—	Opinion of 16 September 2021 concerning 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride; Basic Red 1;

—	Opinion of 16 September 2021 concerning picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide;

—	Opinion of 16 September 2021 concerning diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea;

—	Opinion of 16 September 2021 concerning diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide;

—	Opinion of 16 September 2021 concerning hydrogen sulphide, hydrogen sulfide;

—	Opinion of 16 September 2021 concerning benzyl alcohol;

—	Opinion of 16 September 2021 concerning resorcinol; 1,3-benzenediol;

—	Opinion of 16 September 2021 concerning 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A;

—	Opinion of 16 September 2021 concerning a reassessment at the request of the Commission to review the harmonised classification of lead (environment);

—	Opinion of 26 November 2021 concerning 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol;

—	Opinion of 26 November 2021 concerning 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol;

—	Opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, N,N’-diphenyl-p-phenylene diamine and N,N’-di-o-tolyl-phenylene diamine;

—	Opinion of 26 November 2021 concerning tetramethylene dimethacrylate;

—	Opinion of 26 November 2021 concerning 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate;

—	Opinion of 26 November 2021 concerning 2,2'-ethylenedioxydiethyl dimethacrylate;

—	Opinion of 26 November 2021 concerning bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate;

—	Opinion of 26 November 2021 concerning 4-methylimidazole;

—	Opinion of 26 November 2021 concerning sulfur dioxide;

—	Opinion of 26 November 2021 concerning 1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one;

—	Opinion of 26 November 2021 concerning benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate.

(3)

The Commission has received additional information from stakeholders contesting the scientific assessment set out in the RAC opinion of 26 November 2021 concerning 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. and in the RAC opinion of 16 September 2021 concerning dibutyltin oxide. The additional information has been assessed and has not been found sufficient to cast doubts on the scientific analysis contained in the RAC opinions. It is therefore appropriate to introduce the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions.

(4)

The RAC opinion of 16 September 2021 concerning the environmental toxicity of lead put forward various possible options to update the harmonised classification of lead for aquatic toxicity. These options give the possibility to either have a single entry for both lead in powder form (‘lead powder’) and in massive form (‘lead massive’) or to keep two separate entries, one for each form. However, as data for lead massive indicates a lower dissolution in water than for lead powder, a calculation in accordance with Part 4 of Annex I to Regulation (EC) No 1272/2008 leads to a less severe classification for lead massive. It is therefore appropriate to amend the existing aquatic toxicity classification for lead powder with regard to the M-factor and to introduce a different aquatic toxicity classification for lead massive.

(5)	In light of the RAC opinions, it is therefore appropriate to introduce or update the harmonised classification and labelling of the substances concerned on the basis of the assessment made in those opinions and following the further assessments.

(6)	Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(7)

As regards the classification of methyl methacrylate as a respiratory sensitiser and the classification of lithium carbonate, lithium chloride and lithium hydroxide as reproductive toxic substances the Commission has received additional information from stakeholders after obtaining the RAC opinions of 18 March 2021 and of 16 September 2021 respectively concerning those substances. Since that new scientific information requires further assessment by RAC, methyl methacrylate, lithium carbonate, lithium chloride and lithium hydroxide recommended in the RAC opinions should not be subject to harmonised classification and labelling at this stage.

(8)

Compliance with the new or updated harmonised classifications should not be required immediately as a certain period of time is necessary to allow suppliers to adapt the labelling and packaging of substances and mixtures to the new or updated classifications and to sell existing stocks subject to the pre-existing regulatory requirements. That period of time is also necessary to allow suppliers sufficient time to take the actions required to ensure continuing compliance with other legal requirements following the changes made under this Regulation. Suppliers should, however, have the possibility to apply the new or updated harmonised classifications, and to adapt the labelling and packaging accordingly, on a voluntary basis before the date of application of this Regulation, to ensure a high level of protection of human health and of the environment and to provide sufficient flexibility to suppliers,

HAS ADOPTED THIS REGULATION:

Article 1

Annex VI to Regulation (EC) No 1272/2008 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2025.

However, suppliers may already before that date classify, label and package substances and mixtures in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 October 2023.

For the Commission

The President

Ursula VON DER LEYEN

(1) OJ L 353, 31.12.2008, p. 1.

(2) The opinions are accessible via the following website: https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/name/-/ecNumber/-/casNumber/-/dte_receiptFrom/-/dte_receiptTo/-/prc_public_status/Opinion+Adopted/dte_withdrawnFrom/-/dte_withdrawnTo/-/sbm_expected_submissionFrom/-/sbm_expected_submissionTo/-/dte_finalise_deadlineFrom/-/dte_finalise_deadlineTo/-/haz_addional_hazard/-/lec_submitter/-/dte_assessmentFrom/-/dte_assessmentTo/-/prc_regulatory_programme/-/.The opinion of 16 September 2021 concerning a reassessment at the request of the Commission is accessible via the following website: https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment/opinions-of-the-rac-adopted-under-specific-echa-s-executive-director-requests.

ANNEX

In Annex VI to Regulation (EC) No 1272/2008, Table 3 of Part 3 is amended as follows:

(1)

the following entries are inserted following the order of the index numbers corresponding to each entry:

Index No	Chemical Name	EC No	CAS No	Classification		Labelling			Specific Conc. Limits, M- factors and ATE	Notes
Index No	Chemical Name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M- factors and ATE	Notes
‘015-204-00-5	benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate	479-100-5	577705-90-9	Repr. 1B	H360F	GHS08 Dgr	H360F’
‘015-205-00-0	benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)	278-305-5	75768-65-9	Repr. 1B	H360F	GHS08 Dgr	H360F’
‘015-206-00-6	reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1)	—	—	Repr. 1B	H360F	GHS08 Dgr	H360F’
‘015-207-00-1	reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1)	—	—	Repr. 1B	H360F	GHS08 Dgr	H360F’
‘015-208-00-7	dimethyl propylphosphonate	242-555-3	18755-43-6	Muta. 1B Repr. 1B	H340 H360Df	GHS08 Dgr	H340 H360Df’
‘050-034-00-5	dibutyltin maleate	201-077-5	78-04-6	Muta. 2 Repr. 1B Acute Tox. 2 Acute Tox. 4 STOT RE 1 Skin Corr. 1 Eye Dam. 1	H341 H360FD H330 H302 H372 (immune system) H314 H318	GHS08 GHS06 GHS05 Dgr	H341 H360FD H330 H302 H372 (immune system) H314		inhalation: ATE = 0,317 mg/L (dusts or mists) oral: ATE = 510 mg/kg bw’
‘050-035-00-0	dibutyltin oxide	212-449-1	818-08-6	Muta. 2 Repr. 1B Acute Tox. 3 STOT RE 1 Skin Irrit. 2 Eye Dam. 1	H341 H360FD H301 H372 (immune system) H315 H318	GHS08 GHS06 GHS05 Dgr	H341 H360FD H301 H372 (immune system) H315 H318		oral: ATE = 170 mg/kg bw’
‘603-244-00-1	reaction mass of 1-(2,3-epoxypropoxy)–2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane	—	—	Muta. 2 Repr. 1B	H341 H360F	GHS08 Dgr	H341 H360F’
‘603-245-00-7	2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol	221-665-5	3179-89-3	Skin Sens. 1	H317	GHS07 Wng	H317’
‘603-246-00-2	3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol	211-477-1	647-42-7	STOT RE 2 Aquatic Chronic 1	H373 (teeth, bones) H410	GHS08 GHS09 Wng	H373 (teeth, bones) H410		M = 1’
‘604-099-00-7	4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF	216-036-7	1478-61-1	Repr. 1B	H360F	GHS08 Dgr	H360F’
‘604-100-00-0	nonylphenol, branched and linear, ethoxylated (with average molecular weight ≤ 1 540 g/mol) [includes ortho-, meta-, para- isomers or any combination thereof]	500-315-8 500-024-6 500-045-0 500-209-1 248-762-5 243-816-4 248-291-5 — 230-770-5 248-743-1 247-555-7 248-293-6 — and others	127087-87-0 9016-45-9 26027-38-3 68412-54-4 27986-36-3 20427-84-3 27176-93-8 1119449-38-5 7311-27-5 27942-27-4 26264-02-8 27177-05-5 14409-72-4 and others	Aquatic Acute 1 Aquatic Chronic 1	H400 H410	GHS09 Wng	H410		M = 1 M = 10’
‘606-155-00-6	cinnamaldehyde; 3-phenylprop-2-enal; cinnamic aldehyde; cinnamal; [1] (2E)-3-phenylprop-2-enal [2]	203-213-9 [1] - [2]	104-55-2 [1] 14371-10-9 [2]	Skin Sens. 1A	H317	GHS07 Wng	H317		Skin Sens. 1; H317: C ≥ 0,01 %’
‘607-766-00-0	tetramethylene dimethacrylate	218-218-1	2082-81-7	Skin Sens. 1B	H317	GHS07 Wng	H317’
‘607-767-00-6	7,7,9(or 7,9,9)-trimethyl–4,13-dioxo–3,14-dioxa–5,12-diazahexadecane–1,16-diyl bismethacrylate	276-957-5	72869-86-4	Skin Sens. 1B	H317	GHS07 Wng	H317’
‘607-768-00-1	2,2'-ethylenedioxydiethyl dimethacrylate	203-652-6	109-16-0	Skin Sens. 1B	H317	GHS07 Wng	H317’
‘607-769-00-7	bifenox (ISO); methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate	255-894-7	42576-02-3	Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1	H302 H400 H410	GHS07 GHS09 Wng	H302 H410		oral: ATE = 1 500 mg/kg bw M = 1 000 M = 1 000 ’
‘612-295-00-9	benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine	217-465-2	1861-40-1	Carc. 2 Repr. 2 Skin Irrit. 2 Eye Irrit. 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H351 H361d H315 H319 H317 H400 H410	GHS08 GHS07 GHS09 Wng	H351 H361d H315 H319 H317 H410		M = 10 M = 10’
‘612-296-00-4	N,N-dimethyl-p-toluidine	202-805-4	99-97-8	Carc. 1B Acute Tox. 4 Acute Tox. 3 STOT RE 2 Aquatic Chronic 3	H350 H332 H301 H373 (blood system, respiratory tract) H412	GHS08 GHS06 Dgr	H350 H332 H301 H373 (blood system, respiratory tract) H412		inhalation: ATE = 1,4 mg/L (dusts or mists) oral: ATE = 140 mg/kg bw’
‘612-297-00-X	1-phenylethan-1-one (1-phenylethylidene)hydrazone	211-979-0	729-43-1	Skin Sens. 1	H317	GHS07 Wng	H317’
‘612-298-00-5	1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.;	273-227-8	68953-84-4	Repr. 1B Skin Sens. 1	H360FD H317	GHS08 GHS07 Dgr	H360FD H317’
‘613-346-00-8	4-nitrosomorpholine	—	59-89-2	Carc. 1B Muta. 2 STOT RE 1	H350 H341 H372 (liver)	GHS08 Dgr	H350 H341 H372 (liver)		Carc. 1B; H350: C ≥ 0,001 %’
‘613-347-00-3	difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl–1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether	—	119446-68-3	Carc. 2 Acute Tox. 4 Eye Irrit. 2 Aquatic Acute 1 Aquatic Chronic 1	H351 H302 H319 H400 H410	GHS08 GHS07 GHS09 Wng	H351 H302 H319 H410		oral: ATE = 1 450 mg/kg bw M = 10 M = 10’
‘613-348-00-9	9-[2-(ethoxycarbonyl)phenyl]–3,6-bis(ethylamino)–2,7-dimethylxanthylium chloride; Basic Red 1	213-584-9	989-38-8	Acute Tox. 3 Eye Dam. 1 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H301 H318 H317 H400 H410	GHS06 GHS05 GHS09 Dgr	H301 H318 H317 H410		oral: ATE = 280 mg/kg bw M = 10 M = 1’
‘613-349-00-4	4-methylimidazole	212-497-3	822-36-6	Carc. 1B Repr. 1B	H350 H360Fd	GHS08 Dgr	H350 H360Fd’
‘615-051-00-X	3,3'-dimethylbiphenyl–4,4'-diyl diisocyanate	202-112-7	91-97-4	Carc. 2 Resp. Sens. 1 Skin Sens. 1A	H351 H334 H317	GHS08 Dgr	H351 H334 H317		Skin Sens. 1A; H317: C ≥ 0,001 %’
‘616-241-00-5	foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea	—	173159-57-4	Carc. 2 Aquatic Acute 1 Aquatic Chronic 1	H351 H400 H410	GHS08 GHS09 Wng	H351 H410		M = 1 000 M = 100’
‘616-242-00-0	picolinafen (ISO); N-(4-fluorophenyl)-6-[3-(trifluoromethyl)phenoxy]pyridine-2-carboxamide; 4′-fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide	—	137641-05-5	STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1	H373 (blood system, thyroid) H400 H410	GHS08 GHS09 Wng	H373 (blood system, thyroid) H410		M = 1 000 M = 1 000 ’

(2)

the entries corresponding to index numbers 006-015-00-9; 015-203-00-X; 016-001-00-4; 016-011-00-9; 017-004-00-3; 017-005-00-9; 082-013-00-1; 082-014-00-7; 603-057-00-5; 604-010-00-1; 604-074-00-0; 606-034-00-8; 607-032-00-X; 607-034-00-0; 607-223-00-8; 607-246-00-3; 612-004-00-5; 612-049-00-0; 612-056-00-9; 613-088-00-6; 613-127-00-7; 613-307-00-5; 616-035-00-5; 616-104-00-X are replaced by the following entries respectively:

Index No	Chemical Name	EC No	CAS No	Classification		Labelling			Specific Conc. Limits, M-factors and ATE	Notes
Index No	Chemical Name	EC No	CAS No	Hazard Class and Category Code(s)	Hazard statement Code(s)	Pictogram, Signal Word Code(s)	Hazard statement Code(s)	Suppl. Hazard statement Code(s)	Specific Conc. Limits, M-factors and ATE	Notes
‘006-015-00-9	diuron (ISO); 3-(3,4-dichlorophenyl)–1,1-dimethylurea	206-354-4	330-54-1	Carc. 1B STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1	H350 H373 (blood system) H400 H410	GHS08 GHS09 Dgr	H350 H373 (blood system) H410		M = 100 M = 100’
‘015-203-00-X	diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide	278-355-8	75980-60-8	Repr. 1B Skin Sens. 1B	H360Fd H317	GHS08 GHS07 Dgr	H360Fd H317’
‘016-001-00-4	hydrogen sulphide, hydrogen sulfide	231-977-3	7783-06-4	Flam. Gas 1A Press. Gas Acute Tox. 2 Aquatic Acute 1	H220 H330 H400	GHS02 GHS06 GHS09 Dgr	H220 H330 H400		inhalation: ATE = 440 ppmV (gases)	U’
‘016-011-00-9	sulphur dioxide; sulfur dioxide	231-195-2	7446-09-5	Press. Gas Acute Tox. 3 STOT SE 1 Skin. Corr. 1B	H331 H370 (respiratory system) (inhalation) H314	GHS04 GHS06 GHS08 GHS05 Dgr	H331 H370 (respiratory system) (inhalation) H314		inhalation: ATE = 1 000 ppmV (gases)	U, 5’
‘017-004-00-3	potassium chlorate	223-289-7	3811-04-9	Ox. Sol. 1 Acute Tox. 3	H271 H301	GHS03 GHS06 Dgr	H271 H301		oral: ATE = 100 mg/kg bw’
‘017-005-00-9	sodium chlorate	231-887-4	7775-09-9	Ox. Sol. 1 Acute Tox. 3	H271 H301	GHS03 GHS06 Dgr	H271 H301		oral: ATE = 100 mg/kg bw’
‘082-013-00-1	lead powder; [particle diameter < 1 mm]	231-100-4	7439-92-1	Repr. 1A Lact. Aquatic Acute 1 Aquatic Chronic 1	H360FD H362 H400 H410	GHS08 GHS09 Dgr	H360FD H362 H410		Repr. 1A; H360D: C ≥ 0,03 % M = 10 M = 100’
‘082-014-00-7	lead massive: [particle diameter ≥ 1 mm]	231-100-4	7439-92-1	Repr. 1A Lact. Aquatic Chronic 1	H360FD H362 H410	GHS08 GHS09 Dgr	H360FD H362 H410		M = 10’
‘603-057-00-5	benzyl alcohol	202-859-9	100-51-6	Acute Tox. 4 Eye Irrit. 2 Skin Sens. 1B	H302 H319 H317	GHS07 Wng	H302 H319 H317		oral: ATE = 1 200 mg/kg bw’
‘604-010-00-1	resorcinol; 1,3-benzenediol	203-585-2	108-46-3	Acute Tox. 4 STOT SE 1 Skin Irrit. 2 Eye Irrit. 2 Skin Sens. 1B Aquatic Acute 1	H302 H370 (nervous system) H315 H319 H317 H400	GHS07 GHS08 GHS09 Dgr	H302 H370 (nervous system) H315 H319 H317 H400		oral: ATE = 500 mg/kg bw M = 1’
‘604-074-00-0	2,2',6,6'-tetrabromo–4,4'-isopropylidenediphenol; tetrabromobisphenol-A	201-236-9	79-94-7	Carc. 1B Aquatic Acute 1 Aquatic Chronic 1	H350 H400 H410	GHS08 GHS09 Dgr	H350 H410’
‘606-034-00-8	metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one	244-209-7	21087-64-9	Acute Tox. 4 STOT RE 2 Aquatic Acute 1 Aquatic Chronic 1	H302 H373 (blood system) H400 H410	GHS07 GHS08 GHS09 Wng	H302 H373 (blood system) H410		oral: ATE = 320 mg/kg bw M = 10 M = 10’
‘607-032-00-X	ethyl acrylate	205-438-8	140-88-5	Flam. Liq. 2 Acute Tox. 3 Acute Tox. 4 Acute Tox. 4 STOT SE 3 Skin Irrit. 2 Eye Irrit. 2 Skin Sens. 1	H225 H331 H312 H302 H335 H315 H319 H317	GHS02 GHS06 Dgr	H225 H331 H312 H302 H335 H315 H319 H317		inhalation: ATE = 9 mg/L (vapours) dermal: ATE = 1 800 mg/kg bw oral: ATE = 1 120 mg/kg bw STOT SE 3; H335: C ≥ 5 % Skin Irrit. 2; H315: C ≥ 5 % Eye Irrit. 2; H319: C ≥ 5 %	D’
‘607-034-00-0	methyl acrylate; methyl propenoate	202-500-6	96-33-3	Flam. Liq. 2 Acute Tox. 3 Acute Tox. 4 Acute Tox. 4 STOT SE 3 Skin Irrit. 2 Eye Irrit. 2 Skin Sens. 1	H225 H331 H312 H302 H335 H315 H319 H317	GHS02 GHS06 Dgr	H225 H331 H312 H302 H335 H315 H319 H317		inhalation: ATE = 3 mg/L (vapours) dermal: ATE = 1 100 mg/kg bw oral: ATE = 500 mg/kg bw	D’
‘607-223-00-8	transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate	405-060-5	118712-89-3	Carc. 2 Acute Tox. 4 STOT SE 1 Aquatic Acute 1 Aquatic Chronic 1	H351 H302 H370 (nervous system) H400 H410	GHS08 GHS07 GHS09 Wng	H351 H302 H370 (nervous system) H410	EUH066	oral: ATE = 580 mg/kg bw M = 1 000 M = 1 000 ’
‘607-246-00-3	allyl methacrylate; 2-methyl-2-propenoic acid 2-propenyl ester	202-473-0	96-05-9	Flam. Liq. 3 Acute Tox. 2 Acute Tox. 3 Acute Tox. 4 Aquatic Acute 1	H226 H330 H311 H302 H400	GHS02 GHS06 GHS09 Dgr	H226 H330 H311 H302 H400		inhalation: ATE = 1,5 mg/L (vapours) dermal: ATE = 300 mg/kg bw oral: ATE = 400 mg/kg bw’
‘612-004-00-5	triethylamine	204-469-4	121-44-8	Flam. Liq. 2 Acute Tox. 3 Acute Tox. 3 Acute Tox. 3 Skin Corr. 1A Eye Dam. 1	H225 H331 H311 H301 H314 H318	GHS02 GHS06 GHS05 Dgr	H225 H331 H311 H301 H314		inhalation: ATE = 7,2 mg/L (vapours) dermal: ATE = 300 mg/kg bw oral: ATE = 100 mg/kg bw STOT SE 3; H335: C ≥ 1 %’
‘612-049-00-0	di-n-butylamine	203-921-8	111-92-2	Flam. Liq. 3 Acute Tox. 2 Acute Tox. 3 Acute Tox. 3 Skin Corr. 1B Eye Dam. 1	H226 H330 H311 H301 H314 H318	GHS02 GHS06 GHS05 Dgr	H226 H330 H311 H301 H314	EUH 071	inhalation: ATE = 1,2 mg/L (vapours) dermal: ATE = 300 mg/kg bw oral: ATE = 220 mg/kg bw’
‘612-056-00-9	N,N-dimethyl-m-toluidine; [1] N,N-dimethyl-o-toluidine [2]	204-495-6 [1] 210-199-8 [2]	121-72-2 [1] 609-72-3 [2]	Acute Tox. 3 * Acute Tox. 3 * Acute Tox. 3 * STOT RE 2 * Aquatic Chronic 3	H331 H311 H301 H373 ** H412	GHS06 GHS08 Dgr	H331 H311 H301 H373 ** H412		*	C’
‘613-088-00-6	1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one	220-120-9	2634-33-5	Acute Tox. 2 Acute Tox. 4 Skin Irrit. 2 Eye Dam. 1 Skin Sens. 1A Aquatic Acute 1 Aquatic Chronic 1	H330 H302 H315 H318 H317 H400 H410	GHS06 GHS05 GHS09 Dgr	H330 H302 H315 H318 H317 H410		inhalation: ATE = 0,21 mg/L (dusts or mists) oral: ATE = 450 mg/kg bw Skin Sens. 1A; H317: C ≥ 0,036 % M = 1 M = 1’
‘613-127-00-7	mepiquat chloride (ISO); 1,1-dimethylpiperidinium chloride	246-147-6	24307-26-4	Acute Tox. 4 Acute Tox. 3 Aquatic Chronic 3	H332 H301 H412	GHS06 Dgr	H332 H301 H412		inhalation: ATE = 2,8 mg/L (dusts or mists) oral: ATE = 270 mg/kg bw’
‘613-307-00-5	clothianidin (ISO); (E)-1-(2-chloro–1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine	433-460-1	210880-92-5	Repr. 2 Acute Tox. 4 STOT SE 1 Aquatic Acute 1 Aquatic Chronic 1	H361f H302 H370 (nervous system) H400 H410	GHS08 GHS07 GHS09 Dgr	H361f H302 H370 (nervous system) H410		oral: ATE = 390 mg/kg bw M = 10 M = 100’
‘616-035-00-5	cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [1] (2E)-2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [2]	261-043-0 [1] - [2]	57966-95-7 [1] 166900-80-7 [2]	Repr. 2 Acute Tox. 4 STOT RE 2 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1	H361fd H302 H373 (blood system, thymus, eyes) H317 H400 H410	GHS08 GHS07 GHS09 Wng	H361fd H302 H373 (blood system, thymus, eyes) H317 H410		oral: ATE = 360 mg/kg bw M = 1 M = 1’
‘616-104-00-X	benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-alaninate	275-728-7	71626-11-4	Acute Tox. 4 Aquatic Acute 1 Aquatic Chronic 1	H302 H400 H410	GHS07 GHS09 Wng	H302 H410		oral: ATE = 1 000 mg/kg bw M = 1 M = 1’

ELI: http://data.europa.eu/eli/reg_del/2024/197/oj

ISSN 1977-0677 (electronic edition)

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